Side Effect Reporting

What it Treats

What is ZELBORAF APPROVED FOR?

ZELBORAF is a prescription medicine used to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene.

ZELBORAF is not used to treat melanoma with a normal BRAF gene. Your healthcare provider will perform a test to make sure ZELBORAF is right for you.

ZELBORAF is a prescription medicine used to treat a type of blood cell cancer called Erdheim–Chester disease (ECD), that can affect body tissues and organs, and that has a certain type of abnormal “BRAF” gene.

It is not known if ZELBORAF is safe and effective in children under 18 years of age.

Important Safety Information

What is the most important information I should know about ZELBORAF?

ZELBORAF can cause serious side effects, including:

Risk of new cancers. ZELBORAF may cause certain types of skin cancer called cutaneous squamous cell carcinoma (cuSCC) and keratoacanthoma. New melanoma lesions have occurred in people who take ZELBORAF. ZELBORAF may also cause another type of cancer called non-cutaneous squamous cell carcinoma (non-cuSCC). Talk with your healthcare provider about your risk for these cancers.

Your healthcare provider should check your skin before you start taking ZELBORAF, and every 2 months during treatment with ZELBORAF, to look for any new skin cancers. Your healthcare provider may continue to check your skin for 6 months after you stop taking ZELBORAF.

Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that you get while taking ZELBORAF.

Other blood cancers have happened in some people with Erdheim-Chester Disease (ECD) including those who take ZELBORAF. If you have other blood cancers and take ZELBORAF for ECD, your healthcare provider will monitor your blood cancer through routine blood tests.

Before you take ZELBORAF, tell your healthcare provider about all of your medical conditions, including if you:

Have any heart problems, including a condition called long QT syndrome

Have liver or kidney problems

Have had or are planning to receive radiation therapy

Have been told that you have low blood levels of potassium, calcium, or magnesium

Are pregnant or plan to become pregnant. ZELBORAF can harm your unborn baby.

Females who are able to become pregnant should use effective birth control during treatment with ZELBORAF and for 2 weeks after the final dose of ZELBORAF

Talk to your healthcare provider about birth control methods that may be right for you

Tell your healthcare provider right away if you become pregnant during treatment with ZELBORAF

Are breastfeeding or plan to breastfeed. It is not known if ZELBORAF passes into your breast milk. Do not breastfeed during treatment with ZELBORAF and for 2 weeks after the final dose of ZELBORAF. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking ZELBORAF?

Avoid sunlight during treatment with ZELBORAF. ZELBORAF can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. To help protect against sunburn:

Allergic reactions can happen while taking your ZELBORAF, and can be severe. Stop taking ZELBORAF and get medical help right away if you get any of these symptoms of an allergic reaction:

Rash or redness all over your body

Trouble breathing or swallowing

Swelling of the face, lips, or tongue

Throat tightness or hoarseness

Feel faint

Fast heartbeat

Severe skin reactions. Stop taking ZELBORAF and call your healthcare provider right away if you get a skin rash with any of the following symptoms, because you may have a severe skin reaction:

Blisters on your skin

Blisters or sores in your mouth

Peeling of your skin

Fever

Redness or swelling of your face, hands, or soles of your feet

Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider should do tests before you start taking ZELBORAF and during your treatment with ZELBORAF to check the electrical activity of your heart and your and your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast while taking ZELBORAF. These may be symptoms related to QT prolongation.

Liver injury. Your healthcare provider should do blood tests to check your liver function before you start taking ZELBORAF and during treatment. Tell your healthcare provider right away if you get any of these symptoms of a liver problem during treatment:

Yellowing of your skin or the white part of your eyes

Dark or brown (tea color) urine

Nausea or vomiting

Loss of appetite

Pain on the right side of your stomach

Eye problems. Tell your healthcare provider right away if you get any of these symptoms during treatment with ZELBORAF:

Eye pain, swelling, or redness

Blurred vision or other vision changes

Worsening side effects from radiation treatment that can sometimes be severe or lead to death. Tell your healthcare provider if you have had or are planning to receive radiation therapy.

Kidney injury. Your healthcare provider should do blood tests to check your kidney function before you start taking ZELBORAF and during treatment.

Connective tissue disorders. Tell your healthcare provider if you develop an unusual thickening of the palms of your hands along with tightening of the fingers inward or any unusual thickening of the soles of your feet which may be painful.

The most common side effects of ZELBORAF in melanoma include:

Joint pain

Rash (see “Severe skin reactions” above)

Hair loss

Sunburn or sun sensitivity

Nausea

Itching

Warts

The most common side effects of ZELBORAF in Erdheim-Chester Disease include: